About the Job:SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance the quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.

We are looking for an experienced Principal Clinical Software Engineer to join our growing R&D team.

Job site: 777 Oakmont Lane, Suite 200, Westmont, IL 60559

PRIMARY FUNCTIONS & RESPONSIBILITIES:

Responsible for the architecture, design, development and sustaining efforts of PLM-integrated Image-to-Implant software technology platform.

Develop data-mining techniques to analyze the databases available at SpineCraft;

Develop data processing algorithms to apply the knowledge extracted from existing clinical databases coupled with population analysis in customizing existing spine implants to fit a broader population or new geographic/ethnic markets with unique anatomical features;

Develop a clinical decision support system that uses the clinical databases extracted knowledge to better assist surgeons in evaluating surgical planning and clinical outcomes, and assist design engineer in creating 3D models from CT/MRI images for surgical simulation, reconstruction and rapid prototyping;

Ensure high-quality software and documentation by adhering to regulations, standards and industry best practices;

Ensure that Image-to-Implant software platform will maintain secure management of patient imaging data from initial submission through shipment of the patient-customized implants to the operating room;

Ensure that the PLM system facilitates the digital creation and control of required regulatory compliance records;

Work effectively in cross-functional teams consisting of R&D, RA/QA, and Marketing;

Keep abreast of relevant and new technologies in software development in general, and the medical imaging field in particular.

REQUIREMENTS:

Master’s degree in Computer Science or Engineering Mathematics

10 years of experience in C/ C++ programming.

10 years of experience in software requirements analysis and risk management processes.

10 years of experience in Object-oriented Analysis / Design and Programming methodologies.

5 years of experience in Medical Image Analysis and building software solutions implementing image analysis algorithms with strong command of 2D/3D mathematics and algorithms.

About the Job:SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance the quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.

About the Job:SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.​We are looking for experienced senior/lead product development engineer to join our growing R&D team.

PRIMARY FUNCTIONS & RESPONSIBILITIES:

Lead a cross-functional project team (including both internal and external team members such as spine surgeons) of several new development projects.

Know and apply elements of the Quality System and medical device-related Federal and International standards.

EXPERIENCE & SKILL REQUIREMENTS:

Should have comprehensive experience in all phases of spine instrumentation products development.

Must have a solid understanding of FDA QSR, MDD and ISO-13485 principles

Must have practical working knowledge of anatomy and physiology, especially as related to the spine, spine biomechanics, spine disorders, fundamentals of spine fusion and non-fusion surgery, mechanical test and measurement techniques and methods, manufacturing & inspection methods and processes, FDA and ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.

Must have excellent communication (verbal & written) and organizational skills. Must have demonstrated ability to work effectively in a team environment.

Must be creative and have the ability to independently apply theoretical technical principles to product design.

Must have the ability to apply parametric solid modeling and drafting conventions to design projects.

Must have commanding knowledge of various software packages including Microsoft Office applications, CAD applications (SolidWorks a definite plus) and Engineering Simulation applications (ANSYS or similar).

Must have the ability to prioritize and manage several projects simultaneously.

About the Job:SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.​We are looking for experienced product development engineer to join our growing R&D team.

PRIMARY FUNCTIONS & RESPONSIBILITIES:

Under limited guidance, will perform highly complex engineering duties associated with the design and development of spine implant and instrument systems.

Responsible for different research & development activities that could involve multiple interfaces internal and external to the company.

Interface with surgeons to develop user requirements and evaluate designs.

About the Job:SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.​We are looking for an entry-level product development engineer to join our growing R&D team.

Adhere to company procedures and work within the guidelines of the Quality Policy, Quality Directives, ISO 13485 Standard, FDA 21 CFR PART 820 Requirements, and other applicable Regulatory Requirements.

Participate in research & development programs that could involve multiple interfaces internal and external to the company.

Interface with surgeons to develop user requirements and evaluate designs.

Use SolidWorks 3D CAD system to create, without supervision, 3D solid models and detailed production drawings for implants, instruments and gauges, and process the associated ECOs and DMRs.

Participate in Design Control process for a given program to include Project Planning, Risk Analysis, FMEAs, Design Reviews, DHF creation, etc.

Research, analyze and create intellectual property.

Assist with evaluating and monitoring surgeons’ feedback.

Assist in identifying and interfacing with various vendors to manufacture prototypes and finished devices.

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